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Table 2 Study outcome measures and corresponding questionnaires

From: A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial

Variable Questionnaire Details
Primary Outcome   
Sexual functioning FSFI [36, 45] • Assesses overall sexual functioning
• 19 items; 5- and 6-point Likert scales
• Subscales: sexual desire; arousal; lubrication; orgasm; satisfaction; pain
• Total score*: 2-36/Subscale scores*: desire 1.2-6; arousal 0-6; lubrication 0-6; orgasm 0-6; satisfaction 0-6. Higher score indicates better overall sexual functioning. A subscale score of 0 indicates no sexual activity
• Time frame: past 4 weeks
• Cronbach’s alpha in a gynaecologic cancer survivors group: total score: α = 0.94; subscale scores: 0.85 ≤ α ≤ 0.94 [46]
• We added 4 items (6- and 7-point Likert scales) to assess the average frequency and amount of pleasure experienced during sexual activity without sexual intercourse and sexual activity with sexual intercourse
• As our study sample consists of partnered as well as unpartnered women, we added an answer option ‘not applicable, no partner’ to the two items concerning the partner relationship
Secondary Outcomes   
Credibility of analogue therapy rationales CEQ [47] • Assesses the credibility of the rationales and procedures of the intervention and the optimal CAU control group
• 4 items; 9-point Likert scale
• Subscales: credibility; 1 single item (expectancy)
• Cronbach’s alpha: credibility subscale: 0.81 ≤ α ≤ 0.86 [48]
Generic health-related quality of life related to gynaecological cancer EORTC QLQ-C30 [41] • Assesses QoL of cancer patients
• 30 items; 4- and 7-point Likert scales
• Subscales: 5 function subscales: physical; role; emotional; cognitive; social and 3 symptom subscales: fatigue; nausea/vomiting; pain. Single items: dyspnoea; sleep disturbance; appetite loss; constipation; diarrhoea; financial impact. One global QoL scale
• Subscale scores: 0-100. Higher score indicates higher level of functioning (for the function subscales) and greater degree of symptoms (for symptom subscales and/or single items)
• Time frame: past week
• Cronbach’s alpha: subscales: 0.54 ≤ α ≤ 0.86 [41]
Vaginal symptoms and body image concerns EORTC QLQ-CX24 [37] • Assesses disease-specific and treatment-specific aspects of QoL in patients with cervical cancer
• 24 items; 4-point Likert scale
• Subscales: symptom experience; body image; sexual/vaginal functioning. Single-items: lymphedema; peripheral neuropathy; menopausal symptoms; sexual worry; sexual activity; sexual enjoyment
• Subscale score: 0-100. Higher score indicates better level of functioning (for items regarding sexual activity and sexual enjoyment) and higher level of symptoms (for all other items and scales)
• Time frame: past week (for the subscales and single-items lymphedema, peripheral neuropathy and menopausal symptoms); past 4 weeks (for the single-items sexual worry, sexual activity and sexual enjoyment)
• Cronbach’s alpha: subscales: 0.72 ≤ α ≤ 0.87 [37]
Urological and gastrointestinal symptoms and sexual interest EORTC QLQ-EN24 [42] • Assesses urological and gastrointestinal symptoms, and sexual functioning
• 10 items#; 4-point Likert scale
• Subscales: urological symptoms; gastrointestinal symptoms. Single-item: sexual interest
• Subscale score: 0-100. Higher score indicates higher level of urological and gastrointestinal symptoms and higher sexual interest
• Time frame: past week
• Cronbach’s alpha: subscales: 0.74 ≤ α ≤ 0.75 [42]
Quality of life EQ-5D-5 L [49, 50]] • Assesses (general) health
• 5 items; 5-point Likert scale & Visual Analogue Scale (VAS)
• 5 dimensions: mobility; self-care; usual activities; pain/discomfort; anxiety/depression. One VAS for general health
• Time frame: today
Sexual distress FSDS [39, 45] • Assesses distress related to sexual dysfunction
• 12 items; 5-point Likert scale
• Total score: 0-48. Higher score indicates higher level of sexual distress
• Time frame: past 30 days
• Cronbach’s alpha: 0.86 ≤ α ≤ 0.94 [39]
Fear of coital and non-coital sexual activity FSQ [38] • Assesses aspects of fear of sexuality
• 8 items; 5-point Likert scale
• Subscales: fear of non-penetration sexual activity; fear of coitus/vaginal penetration
• Subscale scores: fear of non-coital sexual activity 0-20; fear of coitus 0-12. Higher score indicates higher fear
• Cronbach’s alpha: 0.82 ≤ α ≤ 0.86 [38]
Psychological distress HADS [43, 51]] • Assesses psychological distress
• 14 items; 4 point Likert scale
• Subscales: depression (HADS-D); anxiety (HADS-A)
• Total score: 0-42/Subscale scores: 0-21. Higher score indicates more psychological distress
• Time frame: past week
• Cronbach’s alpha: HADS-D: 0.67 ≤ α ≤ 0.90; HADS-A: 0.68 ≤ α ≤ 0.93 [52]
Gynaecological cancer treatment related distress IES [REF Brom, 1985; [40, 53] • Assesses current treatment related distress
• 15 items; 4-point scale
• Subscales: intrusion; avoidance
• Total score: 0-75/Subscale scores: intrusion 0-35; avoidance 0-40. Higher score indicates: higher tendency to be triggered by stimuli associated with the traumatic event(s) (for items regarding intrusion); higher tendency to avoid situations that are reminders of the treatment (for items regarding avoidance)
• Time frame: past week
• Cronbach’s alpha: total score: 0.87 ≤ α ≤ 0.96; intrusion subscale: 0.85 ≤ α ≤ 0.95; avoidance subscale: 0.77 ≤ α ≤ 0.91 [53]
Relationship dissatisfaction MMQ Marital scale [44, 54] • Assesses marital dissatisfaction
• 10 items; 9-point Likert scale (range 0-8)
• Total scale-score: 0-80. Higher score indicates higher marital dissatisfaction
• Time frame: past 2 weeks
• Cronbach’s alpha in non-distressed group: 0.87 ≤ α ≤ 0.88 [54]
  1. *The score is calculated based on weighted items
  2. #Due to the overlap between 4 items from the QLQ-EN24 and QLQ-CX24, we only included the remaining 6 items
  3. CAU = Care as usual; CEQ = Credibility/Expectancy Questionnaire; EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; EORTC QLQ-CX24 = European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gynaecological Cancer Module; EORTC QLQ-EN24 = European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module; EQ-5D-5 L = EuroQol 5D-5 L; FSDS = Female Sexual Distress Scale; FSFI = Female Sexual Function Index; FSQ = Fear of Sexuality Questionnaire; HADS = Hospital Anxiety and Depression Scale; IES = Impact of Event Scale; MMQ = Maudsley Marital Questionnaire; QoL = Quality of Life